04 February 2019 | News
The product will be commercialized in Germany by Hormosan Pharma
Lupin has announced the launch of NaMuscla® (mexiletine) in Germany and the United Kingdom (UK). NaMuscla® is approved across the European Union (EU) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders.
These disorders are a group of rare, inherited neuromuscular conditions in which myotonia, the inability to relax muscles following voluntary contraction, is the most prominent clinical symptom. NaMuscla® reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality-of-life and other functional outcomes.
The launch of NaMuscla® in Germany and the UK follows the European Commission’s approval of the product on 18 December 2018. NaMuscla®, designated an Orphan Drug by the European Medicines Agency (EMA), is the first treatment to be licensed across the EU for the symptomatic treatment of myotonia in adults with NDM disorders.
The product will be commercialized in Germany by Hormosan Pharma GmbH, a full subsidiary of Lupin Ltd., and in the UK by Lupin Healthcare (UK) Ltd.
Thierry Volle, President EMEA, Lupin said, “We are delighted to be able to provide patient and market access to NaMuscla® in Germany and the UK. NaMuscla® is the first licensed therapy for myotonia across the EU and offers an effective treatment option for patients living with this life-altering symptom. We look forward to additional launches for patients in other EU territories through 2019 and 2020.”
Lupin has ongoing partnering discussions for the commercialization of NaMuscla® in European territories outside of Germany and the UK.